Or. Admin. R. 333-024-0315

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-024-0315 - Licensure

(1) It shall be unlawful:

(a) For any owner or director of a SOA or a clinical laboratory to perform medical or automated non-medical SOA screening tests without a license issued under this rule unless they have been certified for that testing under the Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, 42.U.S.C. 201 and 263a;

(b) For any person to serve in the capacity of director of an SOA screening laboratory without being qualified as a laboratory director under OAR 333-024-0320(1).

(2) OAR 333-024-0305 through 333-024-0350 apply to all SOA screening laboratories and laboratory personnel within the State of Oregon, except:

(a) Laboratories screening for SOA operated by the United States Government;

(b) Laboratories screening for SOA operated and maintained solely for research or teaching purposes, and that involve no direct patient or public health services;

(c) State Police laboratories screening for SOA as a part of the criminal justice system;

(d) Special category laboratories operated by state or local correctional agencies to monitor inmates and offenders on parole, probation, or post-prison supervision. These special category laboratories must follow the provisions of OAR 333-024-0360.

(3) The Division shall issue and renew licenses to the owners of laboratories screening for SOA who demonstrate to the satisfaction of the Division that:

(a) The SOA laboratory is in compliance with ORS 438.435;

(b) The SOA laboratory is equipped to perform within the scope of its license;

(c) The SOA laboratory meets the standards of the Division for safety, sanitary conditions, plumbing, ventilation, handling of specimens, maintenance of equipment and requirements of general hygiene to ensure protection of the public health.

(4) Requirements for license application; fees, exemptions, expiration; and renewal are as follows:

(a) The application for a license for an SOA screening laboratory shall be made on forms provided by the Division and shall be executed by the owner or one of the owners or by an officer of the firm or corporation owning the laboratory, or in the case of a county or municipality, by the public official responsible for operation of the SOA laboratory, or in the case of an institution, by the administrator of the institution. The application shall contain the names of the owner, the director or directors of the laboratory, the location and physical description of the SOA laboratory, and such other information as the Division may require;

(b) Laboratories must pay an annual or biennial, non-refundable license fee, prior to issuance of a license, as described in OAR 333-024-0012(5)(c);

(c) A laboratory certified in toxicology for medical substance of abuse testing under the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 -- Laboratory Requirements, may also perform that testing for non-medical purposes. No separate substance of abuse screening license or registry is required;

(d) Unless sooner voided, suspended or revoked, all licenses issued under this section expire on June 30 of the one or two year cycle following the date of issuance and shall be renewable in the manner prescribed by the Division;

(e) All monies received by the Division for the licensure of SOA screening laboratories shall be credited to the Division account and shall be used for payment of the expenses of the Division in administering OAR 333-024-0005 through 333-024-0350.

(5) A license issued to the owner of an SOA screening laboratory shall show on its face the names of the owners and directors, the location of the laboratory and the laboratory specialty authorized under the license. The license shall be displayed at all times in a prominent place in the laboratory.

(6) A license issued to the owner of an SOA screening laboratory is not transferable. The license of the SOA laboratory is voided 30 days after a change of its director if it has only one director or if all directors change or a change in the ownership or in the location of the laboratory. In the case of death of a director, the Division shall be notified within five working days. The laboratory shall have 30 days to obtain another qualified director.

(7) Subject to ORS 183.310 to 183.550, the Division may refuse to issue or renew the license or may suspend or revoke the license of any SOA laboratory, if it finds that the owner or director has:

(a) Intentionally made false statements on an application for an SOA laboratory license or any other documents required by the Division, or made any misrepresentation in seeking to obtain or retain a license;

(b) Demonstrated incompetence as defined in OAR 333-024-0325;

(c) Intentionally falsified any report;

(d) Referred a specimen, for examination, to an unlicenced clinical or SOA laboratory in this state, or a laboratory out of state not certified by the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 -- Laboratory Requirements, or an equivalent out of state laboratory, unless the laboratory is exempt under section (2) of this rule;

(e) Misrepresented the scope of laboratory service offered by the SOA laboratory or the laboratory specialty authorized by the license;

(f) Rendered a substances of abuse report performed in another laboratory without designating the name and address of the laboratory in which the test was performed;

(g) Knowingly had professional connection with or permitted the use of the name of the licensed laboratory or its director by a laboratory which is required to but has not obtained a license;

(h) Failed to perform or cause to be performed within the time specified, analysis of test samples as stated in OAR 333-024-0340 or failed to report on the results of such analysis within the specified time;

(i) Failed to permit within a reasonable time the entry or inspection as stated in OAR 333-024-0340(2) and (4);

(j) Failed to continue to meet the requirements of this rule, inclusive; and

(k) Violated any provision of OAR 333-024-0305 through 333-024-0350.

(8) Owner shall be responsible for all aspects of the laboratory.

(9) The substance of abuse screening laboratory must be in compliance with requirements of the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 -- Laboratory Requirements, if medical testing for substances of abuse is performed.

(10) Entities performing only manual, non-automated SOA screens using easily portable screening tests must register with the Division and meet the requirements at OAR 333-024-0365.

(11) Licensed clinical laboratories or SOA screening laboratories performing a combination of medical and manual, non-medical SOA screens are not required to register with the Division and must meet the requirements of OAR 333-024-0365(5)(e) when performing tests which qualify for SOA registration.

(12) Licensed clinical laboratories performing only manual, non-medical SOA screens using easily portable screening tests must register with the Division and meet the requirements of OAR 333-024-0365.

(13) Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations, Part 493 -- Laboratory Requirements, that perform medical and non-medical substance of abuse screening, must comply with 333-024-0305 through 333-024-0350 and 333-024-0365(5)(e).

Or. Admin. R. 333-024-0315

HD 28-1988, f. & cert. ef. 12-7-88; HD 5-1992, f. & cert. ef. 5-15-92; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95; HD 13-1997, f. & cert. ef. 10-16-97; OHD 5-1999, f. & cert. ef. 7-30-99; OHD 9-2000, f. & cert. ef. 11-3-00

Publications: The publication(s) referenced in this rule are available from the agency.

Stat. Auth.: ORS 438.050, 438.130, 438.435(4), (5) & (6) & 438.040

Stats. Implemented: ORS 438.050, 438.130 - 438.160 & 438.435